Duns Number:801895244
Device Description: Endosee Display Module, Docking Station, power cord, USB cable
Catalog Number
-
Brand Name
Endosee System
Version/Model Number
ES9000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K183020
Product Code
FAJ
Product Code Name
Cystoscope And Accessories, Flexible/Rigid
Public Device Record Key
7aa303bd-4b44-4d2e-9cdd-654ee83fb93b
Public Version Date
May 15, 2019
Public Version Number
1
DI Record Publish Date
May 07, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |